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NCT00223704 · ClinicalTrials.gov registry record · Phase 2
Bradykinin Receptor Antagonism During Cardiopulmonary Bypass
A Phase 2 study, sponsored by Vanderbilt University.
- Completed
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
NCT00223704 is a Phase 2 study that has completed, run by Vanderbilt University. The registered enrollment target is 150 participants.
The verdict
NCT00223704, a Phase 2 study, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
Study Summary
Each year over a million patients worldwide undergo cardiac surgery requiring cardiopulmonary bypass (CPB). CPB is associated with significant morbidity including the transfusion of allogenic blood products, inflammation and hemodynamic instability. In fact, approximately 20% of all blood products transfused are associated with coronary artery bypass grafting procedures. Transfusion of allogenic blood products is associated with well-documented morbidity and increased mortality after cardiac surgery. Enhanced fibrinolysis contributes to increased blood product transfusion in the perioperative period. The current proposal tests the central hypothesis that endogenous bradykinin contributes to the hemodynamic, fibrinolytic and inflammatory response to CPB and that bradykinin receptor antagonism will reduce hypotension, inflammation and transfusion requirements. In SPECIFIC AIM 1 we will test the hypothesis that the fibrinolytic and inflammatory response to CPB differ during ACE inhibition and angiotensin II type 1 receptor antagonism. In SPECIFIC AIM 2 we will test the hypothesis that bradykinin B2 receptor antagonism attenuates the hemodynamic, fibrinolytic, and inflammatory response to CPB. In SPECIFIC AIM 3 we will test the hypothesis that bradykinin B2 receptor antagonism reduces the risk of allogenic blood product transfusion in patients undergoing CPB. These studies promise to provide important information regarding the effects of drugs that interrupt the RAS and generate new strategies to reduce morbidity in patients undergoing CPB.
Interventions
- DRUG Placebo
- DRUG HOE 140
- DRUG Aminocaproic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2006-05 |
| Est. Completion | 2012-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00223704
The ClinicalTrials.gov registry entry for NCT00223704 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00223704 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00223704 about?
NCT00223704 is a clinical study titled "Bradykinin Receptor Antagonism During Cardiopulmonary Bypass". Each year over a million patients worldwide undergo cardiac surgery requiring cardiopulmonary bypass (CPB). CPB is associated with significant morbidity including the transfusion of allogenic blood products, inflammation and hemodynamic instability. In fact, approximately 20% of all blood products t...
What is the current status of trial NCT00223704?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2006-05. Estimated completion is 2012-06.
What interventions are being tested in trial NCT00223704?
The interventions under investigation include: Placebo (DRUG), HOE 140 (DRUG), Aminocaproic Acid (DRUG).
Who is sponsoring clinical trial NCT00223704?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
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